Proof of Concept (POC) Study of the Soliton Rapid Acoustic (RAP) for the Treatment of Cellulite

Proof of Concept (POC) Study of the Soliton Rapid Acoustic (RAP) Nov Heavy Device for the Treatment of Cellulite

Feasibility study is to evaluate the safety, tolerability and efficacy of Soliton's Rapid Acoustic Pulse (RAP) device for the treatment of cellulite

Study Overview

• Status: Completed
• Conditions: Cellulite
• Intervention / Treatment: Device: Soliton Rapid Acoustic Pulse (RAP)

Detailed Description

To assess the safety and tolerability of Soliton's RAP Nov Heavy for the treatment of cellulite. To assess the efficacy of Soliton's RAP Nov Heavy device for the temporary improvement in appearance of cellulite in terms of mean change in cellulite severity score (CSS).

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Chestnut Hill, Massachusetts, United States, 02467
      • SkinCare Physicians

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female ages 18-65 years
• Participant seeking treatment of cellulite in the upper lateral thigh areas
• Participant presenting with cellulite Grade I or II on both thighs as graded using the Nurnberger-Muller scale classification (Appendix A)
• Participant has stable weight. Body Mass Index (B.M.I.) is ≤ 30
• Participant will not have any other cellulite treatments for 12 months before and throughout the 3-month follow-up
• Participant is willing to participate in study and adhere to follow-up schedule
• Participant is able to read and comprehend English
• Participant has completed Informed Consent Form

Exclusion Criteria:

• Participant is pregnant or planning to become pregnant during the duration of the study
• Participant has a BMI > 30
• Greater than 10% increase or decrease in body weight within past 6 months
• Cellulite treatment on the thighs or buttocks in the last 12 months (Topical or non-invasive procedure)
• Metal or plastic implants in the area of the treatment (vascular stent, or implants in the hips, knees, etc.)
• Active electronic implants such as pacemakers, defibrillators, cochlear implants, nerve/brain stimulators, drug pump, etc.
• Prior liposuction in the thighs or buttocks or any other invasive procedure to limit cellulite.
• Medical disorder that would hinder the wound healing or immune response (no blood disorder, diabetes, inflammatory disease, etc.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: RAP treatment; Single RAP treatment applied to thigh and multi-treatment applied to the other thigh.	Device: Soliton Rapid Acoustic Pulse (RAP); Treatment of legs and/or buttocks for the temporary improvement in the appearance of cellulite.; Other Names: RAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of SAEs	The primary safety endpoint will be met if all treated Participants are free from serious adverse events (SAEs) attributable to the RAP device immediately post treatment and at the 3-month follow-up visit.	18 weeks
Treatment Tolerability	The primary endpoint will be met if a mean tolerability measure using pain scores averaged across all treated Participants is < 8.0	18 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cellulite improvement	A ≥15% mean reduction in the 0-5-point Cellulite Severity Scale as determined by physician assessment of Participant photographs taken before and 3 months after treatment.	18 weeks

Collaborators and Investigators

• Sponsor: Soliton
• Investigators: Study Director: Christopher C Capelli, MD, Soliton

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2018
• Primary Completion (Actual): August 5, 2019
• Study Completion (Actual): August 5, 2019

Study Registration Dates

• First Submitted: May 31, 2019
• First Submitted That Met QC Criteria: June 7, 2019
• First Posted (Actual): June 10, 2019

Study Record Updates

• Last Update Posted (Actual): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 22, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Manifestations; Cellulite
• Other Study ID Numbers: Soliton 2018-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No